Many diseases begin with inflammation, which if excessive, may overwhelm and kill the patient, or if the patient survives, often leads to a disabling fibrosis, which ultimately may also kill the patient.
A classic example is ARDS (Acute Respiratory Distress Syndrome) which may be initiated by any one of several lung injuries (smoke inhalation, near drowning, some infections, etc.). About one third of these patients die, overwhelmed by inflammatory processes in the lung. In those patients that don't die, there is a high risk of developing interstitial pulmonary fibrosis, which is itself often a progressive and fatal disease. A similar pattern is seen in inflammatory diseases of the liver (such as hepatitis C) which lead to cirrhosis, in inflammatory diseases of the kidney, such as glomerulonephritis, which lead to glomerulosclerosis and renal interstitial fibrosis, and in diseases of the skin, leading to systemic sclerosis (scleroderma). Other diseases with similar patterns include pancreatic fibrosis, bowel inflammations leading to fibrosis and obstruction, and acute burn multiple organ damage.
Recently, evidence has been accumulating that the common condition of inflammation may also underlie many other chronic and debilitating diseases, such as Alzheimer's, heart disease, osteoporosis and diabetes, and that drugs that fight inflammation may have a role in preventing or delaying those diseases, or at least slowing them down. Typically, anti-inflammatory drugs belong to the class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDS), which include ibuprofen and naproxen, aspirin, and prescription drugs known as cox-2-inhibitors, including celecoxib (Celebrex) and rofecoxib (Vioxx) as well as diclofenac (Voltaren), indomethacin (Indocin), and other less commonly used drugs. However, patients at risk for these common and chronic diseases are not encouraged to take anti-inflammatory drugs, other than aspirin, at least in part because regular use of these drugs is not safe for everyone. Side effects can include stomachache or nausea in up to 20 percent of patients, and stomach or intestinal ulcers and bleeding in 2 percent to 4 percent of those who take the drugs for a year, especially for people over 60. The stomach bleeding can occur with little warning, and it can be fatal. Even low doses of aspirin can cause stomach bleeding in some people, and it can also cause a slight increase in the risk of a less common type of stroke, also brought on by cerebral hemorrhage. Anti-inflammatory drugs may make kidney disease worse, and cox-2 drugs have been suggested to cause an increase in the risk of heart attack.
Currently there is no effective therapy for these inflammatory and/or fibrotic diseases. Moreover, anti-inflammatory drugs possess high levels of risk, especially with prolonged use. Thus, what is needed is an effective therapy for inflammatory and/or fibrotic disease; preferably, such therapy is also safe, especially for long-term use.